P2‐289: Effects of testosterone replacement on cognition in men with low testosterone levels and mild cognitive impairment

Abstract

Background: The ADAS-Cog is widely used in AD clinical trials and administered repeatedly during 18-month trials. The ADAS-Cog score decline s by an average of 4.3 to 9.1 points in mild to moderate AD clinical trials over 18-month trials (Schneider and Sano 2009). There has not been systematic investigation into the 11 items that comprise the total ADAS-Cog score and how performance on each item changes over this time period.Methods: Data from the 11-item ADAS-Cog from four ADCS-sponsored trials was examined at baseline, month 6, month 12 and month 18. The average score for each item at each visit was recorded, as well as the individual components that comprise each item. Results: Across the four trials, the ADASCog was administered at baseline (n 1⁄4 2007), month 6 (n 1⁄4 1777), month 12 (n1⁄4 1650), andmonth 18 (n1⁄4 1523). The score onmany individual tasks remained relatively consistent across 18 months for many items and worsened noticeably for others. Items with less than or equal to a 3% increase in the number of subjects unable to complete the task over 18 months include “Make a Fist,” drawing the circle, cube, and naming the middle finger, ring finger and tongs. Orientation test items showed the largest decline with at least 8%more patients making an error in performance on each of the following: month, date, year, day, season, and time of day compared to baseline. Conclusions: While the ADAS-Cog score reliably declined but to a variable extent over 18 months, decline on individual items varied widely, and the orientation items contributed most to the change. Identifying errors on specific items provides information on the pattern of and contributors to change on the ADAS-Cog. The orientation items contributed substantially more to the decline in ADAS-Cog total score. Further investigations will include whether decline in performance on individual items varies by MMSE strata and education.